With the cost of drug development rising and current processes slow and expensive, there is a growing need for new ways to make drugs. 

Speakers:

• Jean-Marie Geoffroy, Pfizer, VP Sterile Injectables Design

The successful execution of technical transfer and PPQ at CDMOs is fundamental to ensuring the quality, robustness, and consistency of pharmaceutical products. By adhering to rigorous protocols, CDMOs can effectively transfer manufacturing processes and establish reliable, robust processes, ultimately contributing to the success of drug development and patient safety. In this presentation, the methods involved in the technical transfer process for intermediates and APIs from the parent company to the CDMO are discussed. 

This includes comprehensive information on the manufacturing process, equipment, analytical methods, and quality control procedures. Effective technical transfer ensures a smooth transition and minimizes any potential risks or deviations during the manufacturing process. Process characterization studies that are employed to evaluate process performance and capability are also discussed. It encompasses the identification, verification, and validation of critical process parameters and establish their acceptable ranges to ensure consistent product quality. 

It is essential to meticulously evaluate and optimize these parameters to establish reliable manufacturing processes. Finally, the presentation includes case studies to illustrate these strategies and successful execution of PPQ batches at the CDMOs, highlighting real-world examples of the benefits derived from effective technical transfer and PPQ processes. Through efficient knowledge transfer, meticulous parameter qualification, and rigorous batch analysis, CDMOs can establish reliable manufacturing processes that ensure the quality, robustness, and consistency of intermediates and APIs.

Speakers: 

• Dr Subramanya Nayak, AbbVie, Director Program Management and External Manufacturing

Uncover the leading edge of pharmaceutical manufacturing as we embark on a guided exploration of innovative solutions designed to boost the efficiency, quality, and sustainability of drug production. Join us to explore how advanced technologies and novel methods are reshaping the pharmaceutical manufacturing landscape.
 

• Breaking the barriers in personalized medicines with flexible manufacturing
• Examining current Quality by Design (QbD) and Risk-Based Approaches in current drug manufacturing practices.

Speakers: 

• Hang Tran, ATS Life Sciences Group, Innovation Technical Product Manager
  

Join us for a series of rapid-fire talks on disruptive manufacturing technologies. 

AI in Manufacturing | 15:00 - 15:15 (EST)

Speakers: 

• Mariano Mattei, Azzur Group, Vice President of Cybersecurity and CISO

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Combining Biology and Chemistry for Smart Manufacturing | 15:15 - 15:30 (EST)

Ingenza’s approach to drug substance production embraces the concept of employing the best of what both chemistry and biology have to offer in route synthesis. By integrating fermentative, biocatalytic and chemical synthetic transformations at any stage in the manufacturing process on substrates and intermediates we are versatile and adaptable to meet the ever increasing complex drug modalities for biological, synthetic and semi-semisynthetic targets which may for instance possess significant structural challenges in regio- and stereo-selective control during preparation.

Our expertise further can define and highlight new opportunities to improve chemo- and bio-conversions through smart manufacturing route design to a given commercial molecular target. Examples include bioderived pharmacological PEGylation of product delivering cleaner manufacturing of product (free of contaminants), superior attachment control and improved processing efficiency.

Speakers: 

• Masha Kononov, Ingenza Ltd., Director of Business Development North America

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Exploring the growing role of 3D printing in pharmaceutical manufacturing | 15:30 - 15:45 (EST)

Exploring the growing role of 3D printing in pharmaceutical manufacturing, including personalized medication and dosage forms - Pharmaceutical 3D printing is a rapidly growing field, with more and more research groups in academia and industry investing time and resources to investigate its use to personalize medicine. 3D printing provides the ability to fabricate small batches of precise structures rapidly, allowing for the personalization of medication with varying dosage, color, flavor, shape, and drug combinations (polypills). This presentation will introduce the most promising 3D printing technologies in the pharmaceutical field and explore their potential to revolutionize pharmaceutical manufacturing in the future.

Speakers: 

• Carlos Bendicho, FABRX, Lead Formulation Scientist

The pharmaceutical industry is facing increasing pressure to reduce costs. One way to reduce costs is to improve manufacturing efficiency. Join our panel, where our experts will review the latest technologies, re-designing processes, and optimizing workflows, drug manufacturers can reduce costs.
 

• Why Expanding your focus to long-term and transformative solutions can mitigate overall costs
• Assessing the patient’s role and how they can improve manufacturing efficiency 
• Reviewing current talent strategy practices to identify the right people
• Why shifting towards cost-effective measures offers an opportunity to embrace patient-centric approaches

Speakers: 

• Pete Smith, Pfizer, Sr. Director, Mfg. Network Strategy
• Kaushik Datta, Haleon plc, Former VP, Head of North America Contract Manufacturing Operations
• Laura Bray, Angels for Change, Chief Change Maker
  
• Dr Subramanya Nayak, AbbVie, Director Program Management and External Manufacturing